PHYENLIMCIDE TOOTHPASTE

Manufacturer
WOORIZ Co.,Ltd. | Korea Life Science Co.,ltd
Effective date
2021-10-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:26

Label at a glance#

ProductPHYENLIMCIDE TOOTHPASTE
Active ingredientSilicon Dioxide
Label structure10 sections

Indications and uses

■ Helps protect against cavities

Dosage and administration

■ Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. ■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. ■ Children under 2 years: Consult a dentist or doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide 15.0%

PURPOSE

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

■ Helps protect against cavities

WARNINGS

WARNINGS SECTION

■ Do not swallow and rinse mouth thoroughly after use
■ For children under 6 years of age, use small amounts of toothpaste.
under the supervision of a guardian to avoid sucking or swallowing.
■ Consult a physician or dentist immediately if a child under 6 years old has
swallowed large quantities.
■ Keep out of the reach of children under 6 years of age.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■ Keep out of the reach of children under 6 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or doctor.
■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
■ Children under 2 years: Consult a dentist or doctor.

Other Information

OTHER SAFETY INFORMATION

■Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Questions

OTC - QUESTIONS SECTION

smartstore.naver.com/wooriz

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

D-sorbitol Solution,L-Menthol,Sophora Extract,Glycerin,Aminocaproic Acid,Geen Tea Extract,Aluminum Chlorohydroxy Allantoinate,Lemon Extract,Mastic Oil,Myrrh Tincture,Sodium Saccharin,Aloe Extract(09),Eucalyptus Globulus Leaf Oil,Xylitol,Water,Sodium Chloride,Carboxymethylcellulose Sodium,Camomille Extract(1),Sodium Cocoyl Glutamate,Peppermint Oil,Chamaecyparis Obtusa Oil,Propolis Extract,Hydroxyapatite,Scutellaria Root Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82336-010-022022-07-29C16284748780-1e4f33bdf-aafd-d8a0-e053-dadaa90a6e4ef60ade6d-282b-4e0d-8eb5-596bf9f05fcb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82336-010-01PHYENLIMCIDE TOOTHPASTE160 g in 1 TUBEPASTE, DENTIFRICE1601
82336-010-02PHYENLIMCIDE TOOTHPASTE1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82336-010PHYENLIMCIDE TOOTHPASTE (SILICON DIOXIDE) PASTE, DENTIFRICE [WOORIZ CO.,LTD.]1Legacy NDC, 2 package rows20211023_f60ade6d-282b-4e0d-8eb5-596bf9f05fcb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82336-01082336-010-01, 82336-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Silicon DioxideETJ7Z6XBU4ACTIB
SORBITOL506T60A25RIACT
LEVOMENTHOLBZ1R15MTK7IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
217302bc-63f0-4592-bdb3-9e7a363fc627f60ade6d-282b-4e0d-8eb5-596bf9f05fcb2021-10-22WarningsExact identifier
spl id: 217302bc-63f0-4592-bdb3-9e7a363fc627
spl set id: f60ade6d-282b-4e0d-8eb5-596bf9f05fcb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.